Virtual Reality vs Standard-of-Care for Comfort During Intravenous Catheterization

Intravenous Catheterization Clinical Trial

Official title:

A Pragmatic Randomized Controlled Trial of Virtual Reality vs Standard-of-Care for Comfort During Intravenous Catheterization

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03681730
• Other study ID #: H18-00771
• Status: Recruiting
• Phase: N/A
• Start date: May 2, 2018
• Est. completion date: May 1, 2019

Study information

• Verified date: September 2018
• Source: University of British Columbia
• Contact: Ran D Goldman, MD
• Phone: 604-875-2345
• Email: rgoldman[@]cw.bc.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Children often need an intravenous catheter placement for delivery of fluids and medications, a procedure associated with pain and anxiety. In the Emergency Department topical anesthetics are frequently used.

Virtual Reality (VR) is an immersive experience using sight, sound, and position sense. Using VR may enhance distraction during the painful procedure and may reduce attention to pain.

This study will randomize children (6 - 16 years old) to receive Virtual Reality or standard of care in addition to topical anaesthetics during IV placement procedure. Investigators will measure pain, anxiety and satisfaction, amount of analgesics used and the level of success in placing the IV and compare between the two groups.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 64
• Est. completion date: May 1, 2019
• Est. primary completion date: May 1, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Years to 16 Years

Eligibility

Inclusion Criteria:

• Children age 6 - <17

• The managing physician determines a need for an intravenous catheterization (IV) procedure

• Parents will sign a consent form and children will sign an assent form

Exclusion Criteria:

• Children with conditions that may prohibit participation or evaluation of the procedure (such as developmental delay, autism, others)

• Triage Category 1 (resuscitation)

• Facial features or injury prohibiting wearing the VR goggles

Related Conditions & MeSH terms

• Intravenous Catheterization

Intervention

Device:
• Virtual Reality
Participants wear a Virtual Reality headset that consists of a ASUS phone and a VOX+ Z3 3D Virtual Reality Headset. The phone runs the VR Roller Coaster app to produce the virtual environment.

Locations

Country	Name	City	State
Canada	BC Children's Hospital	Vancouver	British Columbia

Sponsors (1)

Lead Sponsor	Collaborator
University of British Columbia

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain using the Faces Pain Scale - Revised.	Level of pain as reported by children using Faces Pain Scale - Revised. The scale includes six faces that represent progressively more intense features of pain. Children point to the face that best represents their current level of pain. The minimum score is 0 (representing least pain) and the maximum score is 10 (representing greater pain). The scale increase in increments of 2.	Pain is reported by children immediately following completion of the IV start
Secondary	Anxiety using the Venham Situational Anxiety Score	Level of Situational Anxiety as reported by children using the Venham Situational Anxiety Score. This scale includes 8 sets of 2 images of children which represent differing levels of anxiety. Children point to the child that best represents them in that instance. In each set of 2 images of children, one represents greater anxiety (scored as 1) and one represents lesser anxiety (scored as 0). The points from each set of images are totaled. The minimum score is 0 (least anxious) and maximum score is 8 (most anxious).	Anxiety is reported by children immediately following completion of the IV start
Secondary	Patient Satisfaction determined by Global Rating Scale	Satisfaction from the procedure is determined by asking 4 questions on a global rating scale. This scale goes from 0-10 where 0 represents "not very much" and 10 represents "very much." Questions are developed from previous virtual reality research. "Overall, how satisfied are you with pain management during plastic surgery?" "Overall, how satisfied are you with anxiety management during plastic surgery?" "To what extent did you feel like you went into the virtual world?" "How much fun did you have while playing in the virtual world?" These questions will be analyzed individually not summed.	Satisfaction questions are reported by children immediately following completion of the IV start
Secondary	Patient Satisfaction determined qualitatively by an open ended question	Satisfaction from the procedure is determined qualitatively. Children are asked "What is your opinion on how the procedure went?" Answers will be recorded in writing and be assessed for themes (similar words, positive or negative language).	Satisfaction questions are reported by children immediately following completion of the IV start
Secondary	Parent Satisfaction determined qualitatively by an open ended question	Satisfaction from the procedure is determined qualitatively. Parents are asked "What is your opinion on how the procedure went?" Answers will be recorded in writing and be assessed for themes (similar words, positive or negative language).	Satisfaction question is reported by parents immediately following completion of the IV start
Secondary	Medication Dose	How much topical or local anesthetics are used and when they are used (24 hour time); how much sedatives are used and when they are used (24 hour time); how much analgesics are used and when they are used (24 hour time).	These will be recorded during the procedure and immediately following the procedure using the patient chart and nursing notes
Secondary	Number of IV Trials Until Success	How many attempts the nurses need to get a functional IV catheter (concealed objective to avoid a Hawthorne effect).	This number will be collected during the procedure
Secondary	Timing	Time in minutes from readiness for procedure (availability of child, staff and equipment) until completion of procedure (nurse does not need to touch the patient anymore) and until discharged from the emergency department (given discharge paperwork).	Documented immediately after patient and family given discharge paperwork